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510(k) K812129

COAT-A-COUNT DIGITOXIN RIA KIT by Diagnostic Products Corp. — Product Code DPG

K812129 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "COAT-A-COUNT DIGITOXIN RIA KIT". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code DPG (Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.), a Class II device regulated under 21 CFR 862.3300. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Device Class
Class II
Regulation Number
862.3300
Review Panel
TX
Submission Type

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code DPG

  • K935229 — OPUS DIGITOXIN (December 22, 1993)
  • K780075 — RIALYZE DIGOXIN (February 28, 1978)

FDA data resources